Professor John Knight, a children’s kidney specialist, is the Managing Director of Ellen Medical Devices and a senior researcher at The George Institute for Global Health. He speaks to POF about Ellen Medical’s Affordable Dialysis System (the world’s first low-cost dialysis system), discusses how IP is supporting their business strategy, and potential investment opportunities…
Q: What is the background and mission of Ellen Medical Devices?
Ellen Medical Devices is owned by The George Institute for Global Health which is a large Australian medical research institute. The George Institute consistently ranks number one in the world for research impact. We undertake large scale clinical trials and epidemiological studies and have a particularly strong interest in the translation of our research into practical policy changes that will improve the health of people. The George Institute has had a direct impact on the health of hundreds of millions of people around the world as a result of the research that we’ve done. Along with Australia, we have offices in India, China and the UK and a network of experts and collaborators throughout the world, including in the US. In 2010 we discovered there were around 10 million people in the world who needed dialysis for kidney failure, but only approx. 2.6 million people were receiving dialysis. The sole reason many couldn’t receive dialysis is because they couldn’t afford it.
Here in Australia, dialysis costs around $85,000 per patient per year. The Australian community picks up the full cost through the taxation system, and so all Australians can access the treatment. Unfortunately that’s not the case in many developing countries and so many cannot access treatment. The need for dialysis is growing around the world because of the growing epidemic of diabetes and high blood pressure which can cause kidney failure. The numbers we found in 2010 are likely to be 50% higher today. The George Institute published our findings in The Lancet in 2015 and as a follow up, announced our US$100,000 Affordable Dialysis Prize.
We received entries from all over the world with innovative approaches to low-cost dialysis. The international judging panel unanimously awarded the prize to an Irish engineer, Vincent Garvey, as he came up with a brilliant breakthrough invention. Vincent asked the George to form a partnership with him – and Ellen Medical Devices was founded. We set about building a prototype at the start of 2017 and have been going from strength to strength over the last three years. We’ve now reached the stage where we have a robust system which is ready to test with patients, which we hope to do for the first time at the end of this year.
Q: What are the key differences between the Ellen Medical Dialysis system and other machines on the market?
There are two forms of dialysis. There’s hemodialysis (HD) which purifies the blood and is the most common form of dialysis. For HD you need to attach yourself to a machine for five hours a day, three days a week – obviously a very time consuming process. In Australia, about 70% of patients are receiving this form of dialysis. It’s more expensive than the other dialysis on the market, which is called peritoneal dialysis (PD). To start on PD, a surgeon will insert a silicone tube about the size of a drinking straw into your stomach which has a connector on the end. The patient is taught to connect a two-litre bag of fluid containing some salt and some sugar to the connector, and hang it up on a hook. Then by gravity the two litres of fluid drains into your stomach and all of the waste products in your body can diffuse out into the fluid. This procedure can be safely performed at home. Recently there’s been a global trend towards PD but for historical and also for commercial reasons, HD is still much more common, partly because it is also much more profitable than PD for the supplier.
PD bags are made in a large factory – there’s just one for the whole of Australia and NZ. The manufacturing process is quite expensive and the bags of fluid which weigh 2kg each are shipped on trucks to the patient’s home. Vincent realised there was an opportunity to simplify this process if you could use water from the tap. So his invention is in two parts. The first is a small pure water distiller which can sit on the kitchen table and can use water from the tap (or rain or river water). It boils the water and cools it down and makes it into distilled water of sufficient purity for medical purposes. The second part of the invention is a plastic bag full of a concentrate of salt and sugar. Instead of weighing 2kg, it only weighs 120 grams. So, we can make the bags with the concentrate very inexpensively and provide them to the patient. The patient can fill the bag with water in their own home and then use it for PD. The benefits are you save on the shipping costs and save on the expensive centralised manufacturing costs, and in volume you can drive the price down to roughly five times less than current prices.
This would reset the price point for this treatment and make it available to millions of people around the world who are currently missing out. Our system will also work very well for urgent dialysis – for example for the many Covid-19 patients who have experienced kidney failure, or for children with kidney failure due to dehydration, for whom a few days of urgent dialysis can be lifesaving.
Q: How is IP supporting your business strategy?
Protecting our IP is critical for the success of the company. As with all medical treatments, unless there’s a reasonable return on investment, there are no sustainable clinical outcomes. The expertise of the POF team has been a wonderful help to us as we protect our innovative ideas in many different countries around the world. Very soon, we’re going to be looking for a commercial partner who can help us roll our dialysis system out globally. The ideal commercial partner will be a major player who’s already active in medical devices, and has a global footprint, sales forces, clinical support teams and warehouses in different countries around the world, and who could deliver our system to the clinics, working in local languages. There’s already been a huge amount of interest from the international medical devices community. Obviously, whoever partners with us would want to be able to rely on the fact that the IP is protected and our patents are strong. We’ve now reached the stage where the patent applications are being evaluated in different countries around the world, and our first patent application in the US has been allowed and a patent will be granted shortly. We want to make an impact on the health of millions of people, particularly some of the most disadvantaged people in the world, while creating and running a sustainable business.
Having properly protected IP is essential to achieve that success for our company.
Q: When will the Affordable Dialysis machine be available to market and what are the next steps?
We expect to have approval by the Australian Therapeutic Goods Administration (TGA) in two years’ time and for our treatments to be available in the clinic shortly thereafter. The TGA is the regulator in Australia who approves all drugs or medical devices. They usually take 12 months to approve a medical device, but they’re running slower now because of COVID. So we are now looking at early 2023 if everything goes according to plan. Australian approval is critically important because many developing countries rely on the judgments of the TGA for local approval. We have reached the point now in the development of this project where we are actively seeking conversations with potential investors as commercial partners. We’re very proud that we’ve raised approx. $5.4 million in capital to support this company.
The George Institute has put in a significant amount of money, and we were fortunate to find some critically important private philanthropic donors earlier on. Our two key sponsors have been the New South Wales Government, through NSW Health. The other funder who also gave us more than AU$2 million is the Paul Ramsay Foundation, who had the vision to understand very early in the process what we were trying to do, and to invest in our company. We will always be grateful to them all.
This article is republished, with permission, from Inspire, the publication of Phillips Ormonde Fitzpatrick. Access original article here.